WO1997037619A1 - Intervertebral implant - Google Patents

Intervertebral implant Download PDF

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Publication number
WO1997037619A1
WO1997037619A1 PCT/CH1996/000127 CH9600127W WO9737619A1 WO 1997037619 A1 WO1997037619 A1 WO 1997037619A1 CH 9600127 W CH9600127 W CH 9600127W WO 9737619 A1 WO9737619 A1 WO 9737619A1
Authority
WO
WIPO (PCT)
Prior art keywords
implant according
perforations
lateral surface
hollow body
implant
Prior art date
Application number
PCT/CH1996/000127
Other languages
German (de)
French (fr)
Inventor
Philip Procter
Original Assignee
Synthes Ag Chur
Synthes (U.S.A.)
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synthes Ag Chur, Synthes (U.S.A.) filed Critical Synthes Ag Chur
Priority to PCT/CH1996/000127 priority Critical patent/WO1997037619A1/en
Publication of WO1997037619A1 publication Critical patent/WO1997037619A1/en

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Classifications

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/30721—Accessories
    • A61F2/30744—End caps, e.g. for closing an endoprosthetic cavity
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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    • A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures

Definitions

  • the invention relates to an intervertebral implant according to the preamble of patent claim 1.
  • intervertebral implants are used in the fusion of vertebral bodies, especially in the area of the lumbar spine.
  • One to two implants are used per intervertebral space.
  • the known implants can be filled with bone graft and similar materials, but do not allow the targeted introduction and distribution of so-called "bone morphogenic proteins” (BMP), contrast agents, or clinically therapeutic agents, semi-fluid bone substitute materials (e.g. bone meal) ) in the intervertebral space.
  • BMP bone morphogenic proteins
  • contrast agents contrast agents
  • clinically therapeutic agents semi-fluid bone substitute materials
  • semi-fluid bone substitute materials e.g. bone meal
  • the invention seeks to remedy this.
  • the invention is based on the problem of creating an intervertebral implant which, after the implant has been introduced into the intervertebral space, is used for the filling and targeted distribution of semi-fluid bone substitute material enriched with so-called "bone morphogenic proteins” (BMP), contrast agents, or clinical therapeutic agents Similar substances (e.g. bone meal) allowed.
  • the advantage can thus be achieved that with a suitable injection tool after the introduction of the hollow implant into the intervertebral space, thanks to its preferably laterally arranged perforations of different sizes, the free spaces between the implants (if two implants are inserted) in a targeted manner as the implants themselves can also be filled with semi-fluid bone substitute.
  • This technique can be used with minimally vasive and open surgical techniques
  • the spiral structure of the implant designed as a rotating body allows it to be rotated and screwed into the intervertebral space during the insertion phase
  • the implant which is designed as a hollow rotating body, is provided on its front surface with a closure cover or with an insertion opening for receiving a tool.
  • Semi-fluid bone meal or similar substances can be introduced into the hollow body both before and after the implantation.
  • the hollow body is furthermore provided with perforations in the form of hole structures which are preferably arranged longitudinally, initially becoming smaller and smaller at the end. The perforations are preferably limited to a longitudinal strip of the lateral surface arranged parallel to the longitudinal axis of the hollow body.
  • Two such longitudinal strips arranged symmetrically to the longitudinal axis are expediently provided, so that they are in the positions 0 ° and 180 ° to the diameter.
  • the position of these longitudinal strips is marked on the front of the implant.
  • the perforations allow targeted delivery of bone replacement material from the hollow body and the rapid ingrowth of the bone into the hollow body.
  • FIG. 1 is a perspective view of the implant according to the invention
  • FIG. 2 shows a longitudinal section through the implant according to the invention according to FIG. 1 with the representation of the injection / exit behavior of the bone replacement mass;
  • FIG. 3 shows a schematic illustration of two implants according to the invention, introduced into the intervertebral space according to FIG. 1.
  • the intervertebral implant shown in FIGS. 1 and 2 consists essentially of an elongated, cylindrical or prismatic hollow body 1 with a longitudinal axis 2, one
  • the outside of the outer surface 5, of the hollow body 1 designed as a rotating body has a three-dimensional, spiral-shaped structure 6 in the form of an external thread and is provided with a number of perforations 7.
  • the external thread has a pitch of at least 2 rr, preferably at least 2.5 mm, and a depth of 0, t
  • the structuring 6 can also consist of longitudinal grooves running parallel to the longitudinal axis 2 or of any other structural elements, such as teeth, perforations, knobs, tips or grooves, which partially cancel out the planarity of the surface.
  • the front wall 3 of the hollow body 1 is provided with an insertion opening 11 for the introduction of preferably semi-fluid bone substitute material 15.
  • the insertion opening 11 is expediently designed in the form of a deep blind hole which is concentric with the longitudinal axis 2 and which runs outwards into a profile (e.g. hexagon profile) in order to permit the inclusion of a drive tool for screwing in the implant.
  • the perforations 7 are restricted to a longitudinal strip 8 of the jacket surface arranged parallel to the longitudinal axis 2. Two such longitudinal strips 8 arranged symmetrically to the longitudinal axis 2 (0 ° and 180 ° position) can also be provided.
  • the longitudinal strip 8 is flattened in comparison to the remaining, unperforated jacket surface 5, preferably by an amount that corresponds at least to the height of the structuring 6 and is a maximum of 4 mm.
  • the flattening is preferably between 1.0 and 3 mm.
  • the average passage area of the perforations 7 is larger in the central area of the lateral surface 5 than in the area of the part of the lateral surface 5 adjacent to the front and rear wall 3, 4.
  • the average passage area of the perforations 7 in the central region of the lateral surface 5 is between 0.8 and 28.0 mm 2 , preferably between 1.8 and 12.0 mm 2 .
  • the average passage area of the perforations 7 is between 0.3 and 19.0 mm 2 , preferably between 0.5 and 7.0 mm 2 .
  • the number of perforations 7 per longitudinal strip 8 is between 3 and 8, preferably between 4 and 6.
  • the front wall 3 has a removable closure cover 9 with the insertion opening 11.
  • the front wall 3 or the closure cover 11 is provided with markings 10 which indicate the position of the longitudinal strips 8 in order to be able to correctly place the perforations 7 of the implant in the intervertebral space.
  • the implant is preferably made of titanium, titanium alloy, ceramic or a biocompatible plastic.
  • the hollow bodies 1 can be screwed into the cleared intervertebral space 16 between two vertebrae by means of a drive instrument indicated by the arrows 12.
  • Two hollow bodies 1 are preferably introduced into the intervertebral space 16.
  • the Hollow body 1 is now aligned on the basis of its markings 10 (FIG. 1) such that the perforations 7 come to lie freely in the horizontal plane (drawing plane of FIG. 3).
  • a filling instrument 14 indicated in FIG. 2 with so-called "bone morphogenic proteins” (BMP), X-ray contrast media, or clinically therapeutic agents, semi-liquid bone substitute material 15 or similar substances (eg bone meal) enriched in the intervertebral space 16 can be injected become.
  • BMP bone morphogenic proteins
  • X-ray contrast media X-ray contrast media
  • clinically therapeutic agents semi-liquid bone substitute material 15 or similar substances (eg bone meal) enriched in the intervertebral space 16 can be injected become.

Abstract

The invention concerns an intervertebral implant having the shape of an elongate cylindrical hollow body (1) with a longitudinal axis (2), a front wall (3) and a rear wall (4). The exterior of the generated surface (5) of the hollow body (1) comprises a three-dimensionsal structure (6), and the generated surface (5) is provided with perforations (7). When the hollow implant has been introduced into the intervertebral space in a specific manner, the spaces remaining between the implants (if two implants are introduced) and the implants themselves can be filled with semi-liquid bone-replacement compound using a suitable injection tool. This technique can be used in minimally invasive and open operations.

Description

Zwischenwirbel-ImplantatIntervertebral implant
Die Erfindung betrifft ein Zwischenwirbel-Implantat gemäss dem Oberbegriff des Patentanspruchs 1.The invention relates to an intervertebral implant according to the preamble of patent claim 1.
Solche Zwischenwirbel-Implantate werden bei der Fusion von Wirbelkörpern eingesetzt, insbesondere im Bereich der lumbalen Wirbelsäule. Pro Zwischenwirbelräum werden ein bis zwei Implantate verwendet.Such intervertebral implants are used in the fusion of vertebral bodies, especially in the area of the lumbar spine. One to two implants are used per intervertebral space.
Aus dem Stand der Technik sind bereits verschiedene Typen derartiger Zwischenwirbel-Implantate bekannt, welche allerdings folgende Nachteile aufweisen:Various types of such intervertebral implants are already known from the prior art, but they have the following disadvantages:
Die bekannten Implantate lassen sich zwar mit Knochenspänen (bone graft) und ähnlichen Materialien füllen, erlauben aber kein gezieltes Einbringen und Verteilen von mit sogenannten "Bone Morphogenic Proteines" (BMP) , Kontrastmitteln, oder klinisch-therapeutischen Mitteln angereicherten, halbflüssigen Knochenersatzmaterialien (z.B. Knochenmehl) im Zwischenwirbel- räum. Hier will die Erfindung Abhilfe schaffen. Der Erfindung liegt das Problem zugrunde, ein Zwischenwirbel-Implantat zu schaffen, welches nach der Implantateinführung in den Zwischenwirbelraum das Einfüllen und gezielte Verteilen von halbflussigem, mit sogenannten "Bone Morphogenic Proteines" (BMP) , Kontrastmitteln, oder klinisch-therapeutischen Mitteln angereichertem Knochenersatzmaterial oder ahnlichen Substanzen (z.B. Knochenmehl) erlaubt.The known implants can be filled with bone graft and similar materials, but do not allow the targeted introduction and distribution of so-called "bone morphogenic proteins" (BMP), contrast agents, or clinically therapeutic agents, semi-fluid bone substitute materials (e.g. bone meal) ) in the intervertebral space. The invention seeks to remedy this. The invention is based on the problem of creating an intervertebral implant which, after the implant has been introduced into the intervertebral space, is used for the filling and targeted distribution of semi-fluid bone substitute material enriched with so-called "bone morphogenic proteins" (BMP), contrast agents, or clinical therapeutic agents Similar substances (e.g. bone meal) allowed.
Zur Losung dieses Problems ist die eingangs genannte Anordnung durch die Merkmale des kennzeichnenden Teils des unabhängigen Anspruchs 1 weitergebildet .To solve this problem, the arrangement mentioned at the outset is further developed by the features of the characterizing part of independent claim 1.
Damit ist der Vorteil erzielbar, dass mit einem geeigneten Einspritzwerkzeug nach der Einführung des hohlen Implantats in den Zwischenwirbelraum, dank dessen vorzugsweise seitlich angeordneten, unterschiedlich grossen Perforationen, in gezielter Weise sowohl die freibleibenden Räume zwischen den Implantaten (falls zwei Implantate eingeführt werden) , als auch die Implantate selbst mit halbflussiger Knochenersatzmasse gefüllt werden können. Diese Technik ist bei minimalmvasiver und offener Operationstechnik anwendbarThe advantage can thus be achieved that with a suitable injection tool after the introduction of the hollow implant into the intervertebral space, thanks to its preferably laterally arranged perforations of different sizes, the free spaces between the implants (if two implants are inserted) in a targeted manner as the implants themselves can also be filled with semi-fluid bone substitute. This technique can be used with minimally vasive and open surgical techniques
Bei einer bevorzugten Ausführungsform der Erfindung erlaubt die spiralförmige Struktur des als Rotationskörper ausgebildeten Implantats dessen Drehung und Einschraubung in den Zwischenwirbelraum wahrend der Einfuhrungsphase Eine bevorzugte Weiterbildung besteht darin, dass das als hohler Rotationskörper ausgebildete Implantat an seiner Frontfläche mit einen Verschlussdeckel oder mit einer Einführungsöffnung zur Aufnahme eines Werkzeugs versehen ist. Halbflüssige Knochenmehlmassen oder ähnliche Substanzen können sowohl vor, als auch nach dem Implantieren in den Hohlkörper eingebracht werden. Der Hohlkörper ist im weiteren mit Perforationen in Form von vorzugsweise längs angeordneten, anfangs und end-ständig kleiner werdenden Lochstrukturen versehen. Die Perforationen sind dabei vorzugsweise auf einen parallel zur Längsachse des Hohlkörpers angeordneten Längεstreifen der Mantelfläche beschränkt. Zweckmässigerweise sind zwei solcher, symmetrisch zur Längsachse angeordneter Längsstreifen vorgesehen, so dass diese in den Positionen 0° und 180° zum Durchmesser liegen. Um das Implantat während dessen Einführung richtig positionieren zu können ist auf der Frontseite des Implantates die Stellung dieser Längsstreifen markiert.In a preferred embodiment of the invention, the spiral structure of the implant designed as a rotating body allows it to be rotated and screwed into the intervertebral space during the insertion phase A preferred development consists in that the implant, which is designed as a hollow rotating body, is provided on its front surface with a closure cover or with an insertion opening for receiving a tool. Semi-fluid bone meal or similar substances can be introduced into the hollow body both before and after the implantation. The hollow body is furthermore provided with perforations in the form of hole structures which are preferably arranged longitudinally, initially becoming smaller and smaller at the end. The perforations are preferably limited to a longitudinal strip of the lateral surface arranged parallel to the longitudinal axis of the hollow body. Two such longitudinal strips arranged symmetrically to the longitudinal axis are expediently provided, so that they are in the positions 0 ° and 180 ° to the diameter. In order to be able to correctly position the implant during its insertion, the position of these longitudinal strips is marked on the front of the implant.
Die Perforationen erlauben eine gezielte Abgabe von Knochenersatzmaterial aus dem Hohlkörper heraus und das rasche Einwachsen des Knochens in den Hohlkörper.The perforations allow targeted delivery of bone replacement material from the hollow body and the rapid ingrowth of the bone into the hollow body.
Die Erfindung und Weiterbildungen der Erfindung werden im folgenden anhand der teilweise schematischen Darstellung eines Ausführungsbeispiels noch näher erläutert . Es zeigen :The invention and further developments of the invention are explained in more detail below on the basis of the partially schematic illustration of an exemplary embodiment. Show it :
Fig. 1 eine perspektivische Darstellung des erfindungsgemässen Implantats,-1 is a perspective view of the implant according to the invention,
Fig. 2 einen Längsschnitt durch das erfindungsgemässe Implantat nach Fig. 1 mit der Darstellung des Einspritz-/Austrittsverhaltens der Knochenersatzmasse; undFIG. 2 shows a longitudinal section through the implant according to the invention according to FIG. 1 with the representation of the injection / exit behavior of the bone replacement mass; and
Fig. 3 eine schematische Darstellung von zwei in den Zwischenwirbelraum eingeführten erfindungsgemässen Implantaten nach Fig. 1.3 shows a schematic illustration of two implants according to the invention, introduced into the intervertebral space according to FIG. 1.
Das in den Fig. 1 und 2 dargestellte Zwischenwirbel-Implantat besteht im wesentlichen aus einem länglichen, zylindrischen oder prismatischen Hohlkörpers 1 mit einer Längsachse 2, einerThe intervertebral implant shown in FIGS. 1 and 2 consists essentially of an elongated, cylindrical or prismatic hollow body 1 with a longitudinal axis 2, one
Frontwand 3 und einer Hinterwand 4.Front wall 3 and a rear wall 4.
Die Aussenseite der Mantelfläche 5, des als Rotationskörper ausgebildeten Hohlkörpers 1, weist eine dreidimensionale, spiralförmige Strukturierung 6 in Form eines Aussengewindes auf und ist mit einer Anzahl von Perforationen 7 versehen.The outside of the outer surface 5, of the hollow body 1 designed as a rotating body, has a three-dimensional, spiral-shaped structure 6 in the form of an external thread and is provided with a number of perforations 7.
Das Aussengewinde weist eine Steigung von mindestens 2 rr vorzugsweise von mindestens 2,5 mm und eine Tiefe von 0,tThe external thread has a pitch of at least 2 rr, preferably at least 2.5 mm, and a depth of 0, t
2,2 mm, vorzugsweise von 1,5 - 2, 0 mm auf. Die Strukturierung 6 kann auch aus zur Langsachse 2 parallel verlaufenden Längsrillen bestehen oder aus irgendwelchen anderen, die Planarität der Oberfläche stellenweise aufhebenden Strukturelementen, z.B. Zähnchen, Perforationen, Noppen, Spitzen oder , Nuten.2.2 mm, preferably from 1.5-2.0 mm. The structuring 6 can also consist of longitudinal grooves running parallel to the longitudinal axis 2 or of any other structural elements, such as teeth, perforations, knobs, tips or grooves, which partially cancel out the planarity of the surface.
Die Frontwand 3 des Hohlkörpers 1 ist mit einer Emführungs- offnung 11 zur Einführung von vorzugsweise halbflussigem Knochenersatzmaterial 15 versehen. Die Einführungsöffnung 11 ist zweckmässigerweise m Form eines tiefen mit der Langsachse 2 konzentrischen Sacklochs gestaltet, welche nach Aussen hin in ein Profil (z.B. Sechskantprofil) ausläuft, um die Aufnahme eines Antriebswerkzeugeε zur Eindrehung des Implantats zu gestatten.The front wall 3 of the hollow body 1 is provided with an insertion opening 11 for the introduction of preferably semi-fluid bone substitute material 15. The insertion opening 11 is expediently designed in the form of a deep blind hole which is concentric with the longitudinal axis 2 and which runs outwards into a profile (e.g. hexagon profile) in order to permit the inclusion of a drive tool for screwing in the implant.
Die Perforationen 7 sind auf einem parallel zur Längsachse 2 angeordneten Längsstreifen 8 der Mantelflache beschrankt. Es können auch zwei solcher, symmetrisch zur Langsachse 2 (0° und 180° Position) angeordneter Längsstreifen 8 vorgesehen sein. Der Längsstreifen 8 ist im Vergleich zur übrigen, unperforierten Mantelflache 5 abgeflacht, vorzugsweise um einen Betrag, der mindestens der Hohe der Strukturierung 6 entspricht und maximal 4 mm betragt. Vorzugsweise betragt die Abflachung zwischen 1,0 und 3 mm.The perforations 7 are restricted to a longitudinal strip 8 of the jacket surface arranged parallel to the longitudinal axis 2. Two such longitudinal strips 8 arranged symmetrically to the longitudinal axis 2 (0 ° and 180 ° position) can also be provided. The longitudinal strip 8 is flattened in comparison to the remaining, unperforated jacket surface 5, preferably by an amount that corresponds at least to the height of the structuring 6 and is a maximum of 4 mm. The flattening is preferably between 1.0 and 3 mm.
Die durchschnittliche Durchtrittsfläche der Perforationen 7 ist im zentralen Bereich der Mantelfläche 5 grösser als im Bereich des, der Front- und Hinterwand 3,4 benachbarten Teils der Mantelflache 5. Die durchschnittliche Durchtrittstlache der Perforationen 7 im zentralen Bereich der Mantelfläche 5 liegt zwischen 0,8 und 28,0 mm2, vorzugsweise zwischen 1,8 und 12,0 mm2.The average passage area of the perforations 7 is larger in the central area of the lateral surface 5 than in the area of the part of the lateral surface 5 adjacent to the front and rear wall 3, 4. The average passage area of the perforations 7 in the central region of the lateral surface 5 is between 0.8 and 28.0 mm 2 , preferably between 1.8 and 12.0 mm 2 .
Im Bereich des, der Front- und Hinterwand 3,4 benachbarten Teils der Mantelfläche 5 beträgt die durchschnittliche Durchtritts¬ fläche der Perforationen 7 zwischen 0,3 und 19,0 mm2, vorzugsweise zwischen 0,5 und 7,0 mm2.In the area of the part of the lateral surface 5 adjacent to the front and rear walls 3, 4, the average passage area of the perforations 7 is between 0.3 and 19.0 mm 2 , preferably between 0.5 and 7.0 mm 2 .
Die Zahl der Perforationen 7 pro Längsstreifen 8 liegt zwischen 3 und 8, vorzugsweise zwischen 4 und 6.The number of perforations 7 per longitudinal strip 8 is between 3 and 8, preferably between 4 and 6.
Die Frontwand 3 weist bei dem in Fig. 1 dargestellten Implantat einen entfernbaren Verschlussdeckel 9 mit der Einführungsöffnung 11 auf. Die Frontwand 3, bzw. der Verschlussdeckel 11 ist mit Markierungen 10 versehen, welche die Stellung der Längsstreifen 8 angeben, um die Perforationen 7 des Implantats im Zwischenwirbelraum richtig plazieren zu können.In the implant shown in FIG. 1, the front wall 3 has a removable closure cover 9 with the insertion opening 11. The front wall 3 or the closure cover 11 is provided with markings 10 which indicate the position of the longitudinal strips 8 in order to be able to correctly place the perforations 7 of the implant in the intervertebral space.
Das Implantat ist vorzugsweise aus Titan, Titanlegierung, Keramik oder einem biokompatiblen Kunststoff gefertigt.The implant is preferably made of titanium, titanium alloy, ceramic or a biocompatible plastic.
Nachstehend wird nun anhand des Implantats nach den Fig. 1 und 2 dessen klinische Anwendung im Detail beschrieben.The clinical application of the implant according to FIGS. 1 and 2 will now be described in detail below.
Wie in Fig. 3 in einer Horizontalebene dargestellt, können die Hohlkörper 1 mittels eines durch die Pfeile 12 angedeuteten Antriebsinstrumentes in den ausgeräumten Zwischenwirbelraum 16 zwischen zwei Wirbeln eingedreht werden. Vorzugsweise werden zwei Hohlkörper 1 in den Zwischenwirbelraum 16 eingeführt. Der Hohlkörper 1 wird nun anhand seiner Markierungen 10 (Fig. 1) derart ausgerichtet, dass die Perforationen 7 frei in der Horizontalebene (Zeichenebene von Fig. 3) zu liegen kommen. Nun können mit einem in Fig. 2 angedeuteten Einfüllinstrument 14 mit sogenannten "Bone Morphogenic Proteines" (BMP) , Röntgen-Kontrastmitteln, oder klinisch-therapeutischen Mitteln angereichertes, halbflüssiges Knochenersatzmaterial 15 oder ähnliche Substanzen (z.B. Knochenmehl) in den Zwischen¬ wirbelraum 16 eingespritzt werden. As shown in FIG. 3 in a horizontal plane, the hollow bodies 1 can be screwed into the cleared intervertebral space 16 between two vertebrae by means of a drive instrument indicated by the arrows 12. Two hollow bodies 1 are preferably introduced into the intervertebral space 16. The Hollow body 1 is now aligned on the basis of its markings 10 (FIG. 1) such that the perforations 7 come to lie freely in the horizontal plane (drawing plane of FIG. 3). Now, with a filling instrument 14 indicated in FIG. 2 with so-called "bone morphogenic proteins" (BMP), X-ray contrast media, or clinically therapeutic agents, semi-liquid bone substitute material 15 or similar substances (eg bone meal) enriched in the intervertebral space 16 can be injected become.

Claims

Patentansprüche claims
1. Zwischenwirbel-Implantat in Form eines länglichen zylindrischen oder prismatischen Hohlkörpers (1) mit einer Längsachse (2) , einer Frontwand (3) und einer Hinterwand (4) , dadurch gekennzeichnet, dass1. intervertebral implant in the form of an elongated cylindrical or prismatic hollow body (1) with a longitudinal axis (2), a front wall (3) and a rear wall (4), characterized in that
A) die Aussenseite der Mantelfläche (5) des Hohlkörpers (1) mindestens teilweise eine dreidimensionale Strukturierung (6) aufweist; undA) the outside of the outer surface (5) of the hollow body (1) has at least partially a three-dimensional structure (6); and
B) die Mantelfläche (5) des Hohlkörpers (1) mit Perforationen (7) versehen ist.B) the lateral surface (5) of the hollow body (1) is provided with perforations (7).
2. Implantat nach Anspruch 1, dadurch gekennzeichnet, dass die Frontwand (3) eine Einführungsöffnung (11) aufweist zur Einführung von vorzugsweise halbflüssigem Knochenersatzmaterial2. Implant according to claim 1, characterized in that the front wall (3) has an insertion opening (11) for the introduction of preferably semi-fluid bone substitute material
(15) .(15).
3. Implantat nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die Perforationen (7) auf einen parallel zur Längsachse (2) angeordneten Längsstreifen (8) der Mantelfläche beschränkt sind und vorzugsweise zwei solcher, symmetrisch zur Längsachse (2) angeordneter Längsstreifen (8) vorgesehen sind.3. Implant according to claim 1 or 2, characterized in that the perforations (7) are limited to a longitudinal strip (8) of the lateral surface arranged parallel to the longitudinal axis (2) and preferably two such longitudinal strips (8) arranged symmetrically to the longitudinal axis (2) ) are provided.
4. Implantat nach Anspruch 3, dadurch gekennzeichnet, dass die Längsstreifen (8) im Vergleich zur übrigen, unperforierten Mantelfläche (5) abgeflacht sind, vorzugsweise um einen Betrag der mindestens der Höhe der Strukturierung (6) entspricht und maximal 4 mm beträgt. 4. Implant according to claim 3, characterized in that the longitudinal strips (8) are flattened in comparison to the remaining, unperforated lateral surface (5), preferably by an amount which corresponds at least to the height of the structuring (6) and is a maximum of 4 mm.
5. Implantat nach Anspruch 4, dadurch gekennzeichnet, dass die Abflachung zwischen 1,0 und 3, 0 mm beträgt.5. Implant according to claim 4, characterized in that the flattening is between 1.0 and 3.0 mm.
6. Implantat nach einem der Ansprüche 1 - 5, dadurch gekenn¬ zeichnet, dass die durchschnittliche Durchtrittsfläche der Perforationen (7) im zentralen Bereich der Mantelfläche (5) grösser ist als im Bereich des, der Front- und Hinterwand (3,4) benachbarten Teils der Mantelfläche (5) .6. Implant according to one of claims 1-5, characterized gekenn¬ characterized in that the average passage area of the perforations (7) in the central region of the lateral surface (5) is larger than in the region of the front and rear wall (3,4) adjacent part of the lateral surface (5).
7. Implantat nach Anspruch 6, dadurch gekennzeichnet, dass die durchschnittliche Durchtrittsfläche der Perforationen (7) im zentralen Bereich der Mantelfläche (5) zwischen 0,8 und 28,0 mm2, vorzugsweise zwischen 1,8 und 12,0 mm2 liegt.7. Implant according to claim 6, characterized in that the average passage area of the perforations (7) in the central region of the lateral surface (5) is between 0.8 and 28.0 mm 2 , preferably between 1.8 and 12.0 mm 2 .
8. Implantat nach Anspruch 6 oder 7, dadurch gekennzeichnet, dass die durchschnittliche Durchtrittstlache der Perforationen8. Implant according to claim 6 or 7, characterized in that the average passage area of the perforations
(7) im Bereich des, der Front- und Hinterwand (3,4) benachbarten Teils der Mantelfläche (5) zwischen 0,3 und 19,0 mm2, vorzugsweise zwischen 0,5 und 7,0 mm liegt.(7) in the region of the part of the lateral surface (5) adjacent to the front and rear wall (3, 4) is between 0.3 and 19.0 mm 2 , preferably between 0.5 and 7.0 mm.
9. Implantat nach einem der Ansprüche 3 - 8, dadurch gekenn¬ zeichnet, dass die Zahl der Perforationen (7) pro Längsstreifen9. Implant according to one of claims 3 - 8, characterized gekenn¬ characterized in that the number of perforations (7) per longitudinal strip
(8) zwischen 3 und 8, vorzugsweise zwischen 4 und 6 liegt. (8) is between 3 and 8, preferably between 4 and 6.
10. Implantat nach einem der Ansprüche 1 - 9, dadurch gekenn¬ zeichnet, dass der Hohlkörper (1) ein Rotationskörper ist, der auf der Aussenseite seiner Mantelfläche (5) eine spiralförmige Strukturierung (6) aufweist, vorzugsweise in Form eines Aussengewindes .10. Implant according to one of claims 1-9, characterized gekenn¬ characterized in that the hollow body (1) is a rotary body that has a spiral structure (6) on the outside of its outer surface (5), preferably in the form of an external thread.
11. Implantat nach Anspruch 10, dadurch gekennzeichnet, dass die Strukturierung (6) in Form eines Aussengewindes eine Steigung von mindestens 2 mm, vorzugsweise von mindestens 2,5 mm aufweist .11. The implant according to claim 10, characterized in that the structuring (6) in the form of an external thread has a pitch of at least 2 mm, preferably of at least 2.5 mm.
12. Implantat nach Anspruch 10 oder 11, dadurch gekennzeichnet, dass die Strukturierung (6) in Form eines Aussengewindes eine Tiefe von 0,8 - 2,2 mm, vorzugsweise von 1,5 - 2,0 mm aufweist.12. Implant according to claim 10 or 11, characterized in that the structuring (6) in the form of an external thread has a depth of 0.8-2.2 mm, preferably 1.5-2.0 mm.
13. Implantat nach einem der Ansprüche 1 - 12, dadurch gekennzeichnet, dass die Strukturierung (6) aus zur Längsachse13. Implant according to one of claims 1-12, characterized in that the structuring (6) from the longitudinal axis
(2) parallel verlaufenden Längsrillen besteht.(2) there are parallel longitudinal grooves.
14. Implantat nach einem der Ansprüche 1 - 13, dadurch gekennzeichnet, dass die Frontwand (3) einen entfernbaren Verschlussdeckel (9) aufweist.14. Implant according to one of claims 1-13, characterized in that the front wall (3) has a removable closure cover (9).
15. Implantat nach einem der Ansprüche 3 - 14, dadurch gekennzeichnet, dass die Frontwand (3) mit Markierungen (10) versehen ist, welche die Stellung der Längsstreifen (8) angeben. 15. Implant according to one of claims 3-14, characterized in that the front wall (3) is provided with markings (10) which indicate the position of the longitudinal strips (8).
16. Implantat nach einem der Ansprüche 1 - 15, dadurch gekenn¬ zeichnet, dass der Hohlkörper (1) Knochenersatzmaterial enthält, welches vorzugsweise mit "Bone Morphogenic Proteines" (BMP) und/oder Kontrastmitteln angereichert ist. 16. Implant according to one of claims 1-15, characterized gekenn¬ characterized in that the hollow body (1) contains bone replacement material, which is preferably enriched with "bone morphogenic proteins" (BMP) and / or contrast agents.
PCT/CH1996/000127 1996-04-10 1996-04-10 Intervertebral implant WO1997037619A1 (en)

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Application Number Priority Date Filing Date Title
PCT/CH1996/000127 WO1997037619A1 (en) 1996-04-10 1996-04-10 Intervertebral implant

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Publication Number Publication Date
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US7655010B2 (en) 2003-09-30 2010-02-02 Depuy Spine, Inc. Vertebral fusion device and method for using same
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US10653532B2 (en) 2004-04-26 2020-05-19 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US10085851B2 (en) 2004-04-26 2018-10-02 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US9700432B2 (en) 2004-04-26 2017-07-11 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
US9408719B2 (en) 2004-04-26 2016-08-09 DePuy Synthes Products, Inc. Intervertebral prosthesis or disk prosthesis
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US8992618B2 (en) 2004-04-26 2015-03-31 DePuy Synthes Products, LLC Intervertebral prosthesis or disk prosthesis
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US8147500B2 (en) 2006-04-20 2012-04-03 Depuy Spine, Inc. Instrumentation kit for delivering viscous bone filler material
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US9649203B2 (en) 2010-03-16 2017-05-16 Pinnacle Spine Group, Llc Methods of post-filling an intervertebral implant
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